A Nutrition Intervention for Arthritis -3 (WCCR-ARTH3)

NCT03417648 | Completed DMC

• 1 other identifier: WCCR-ARTH-3
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a low-fat, vegan diet improves pain and other subjective symptoms more effectively than a control supplement or a placebo. The principal measure is pain as measured by Visual Analog Scale (VAS) and disease activity as measured by number of painful swollen and tender joints, respectively. The study duration is 36 weeks. This study tests that a low fat, plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Diet, Fat-Restricted, Diet, Vegetarian

Outcome Measures

Primary Outcomes (3)

• Pain Score

  will be measured by visual analog scale from 0%, indicating no pain, to 100%, indicating pain as bad as it could possibly be

  Change in pain score from Baseline at 4 months

• Disease Activity score

  measured by number of painful, swollen and tender joints

  Change in disease activity score from Baseline at 4 months

• Improvement in mood

  measured by the Beck Depression Inventory II (BDI-II).

  Change in mood from Baseline at 4 months

Secondary Outcomes (1)

• Quality of Life

  Change in quality of life from Baseline at 4 months

Study Arms (2)

Plant-based diet

EXPERIMENTAL

The diet group will be asked to follow a low-fat, vegan diet for 16 weeks

Other: Plant-based diet

Supplement

PLACEBO COMPARATOR

The supplement group will follow an unrestricted diet, but will be given a pill containing a small, clinically insignificant amount of omega- 3 oils and vitamin E, which will serve as a placebo.

Other: Supplement

Interventions

Plant-based diet OTHER

Weekly instructions will be given to the participants in the intervention group about following vegan diet.

Plant-based diet

Supplement OTHER

unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E

Also known as: Vitamin E

Supplement

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of rheumatoid arthritis based on 2010 ACR / EULAR Rheumatoid Arthritis Classification Criteria. Classification as "definite RA" is based on:
• the confirmed presence of synovitis in at least 1 joint
• absence of an alternative diagnosis that better explains the synovitis
• and achievement of a total score of 6 or greater (of a possible 10): 24 Joint involvement, designating the metacarpophalangeal joints, proximal interphalangeal joints, the interphalangeal joint of the thumb, second through third metatarsophalangeal joint and wrist as small joints, and elbows, hip joints and knees as large joints:
• Involvement of 1 large joint gives 0 points
• Involvement of 2-10 large joints gives 1 point
• Involvement of 1-3 small joints (with or without involvement of large joints) gives 2 points
• Involvement of 4-10 small joints (with or without involvement of large joints) gives 3 points
• Involvement of more than 10 joints (with involvement of at least 1 small joint) gives 5 points
• Serological parameters - including the rheumatoid factor as well as anti-citrullinated protein antibody (ACPA):
• Negative RF and negative ACPA gives 0 points
• Low-positive RF or low-positive ACPA gives 2 points
• High-positive RF or high-positive ACPA gives 3 points Acute phase reactants: 1 point for elevated erythrocyte sedimentation rate (ESR) or elevated C-reactive protein (CRP) value Duration of arthritis: 1 point for symptoms lasting six weeks or longer
• Continuing or recurring pain (i.e., joint pain daily, unless on pain medication).
• Age at least 18 years

You may not qualify if:

• \< 18 years of age
• Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
• Pregnancy
• Unstable medical or psychiatric illness
• Likely to be disruptive in group sessions (as determined by research staff)
• Already following a low-fat, vegan diet
• Lack of English fluency
• Inability to maintain current medication regimen
• Inability or unwillingness to participate in all components of the study

Sponsors & Collaborators

• Physicians Committee for Responsible Medicine: lead

Study Sites (1)

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

Location

Related Publications (1)

• Barnard ND, Levin S, Crosby L, Flores R, Holubkov R, Kahleova H. A Randomized, Crossover Trial of a Nutritional Intervention for Rheumatoid Arthritis. Am J Lifestyle Med. 2022 Apr 3;19(2):266-275. doi: 10.1177/15598276221081819. eCollection 2025 Feb.

  PMID: 39981557 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Diet, Plant-Based; Dietary Supplements; Vitamin E

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Food; Food and Beverages; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Neal D Barnard

  Physicians Committee for Responsible Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: January 31, 2018
• Study Start: March 8, 2018
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: March 4, 2019

Record last verified: 2019-03

Locations

US (1)